# FDA 483 - Reed-Lane, Inc. - March 03, 2023

Source: https://www.keypedia.com/records/483/reed-lane-inc/18c7c569-fd5d-493b-afcf-1626b5c04145

> FDA 483 for Reed-Lane, Inc. on March 03, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Reed-Lane, Inc.
- Inspection Date: 2023-03-03
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Reed-Lane, Inc., a drug packager in Wayne, NJ, revealed significant deficiencies in its quality control unit, particularly regarding change control and temperature mapping. The firm also failed to adequately investigate product complaints for missing lot numbers and expiry dates, and its equipment cleaning procedures were found to be deficient. These issues indicate a lack of robust quality system oversight.

## Related Officers

- [investigator](https://www.keypedia.com/people/anthony-j-donato/a6dd6e14-529e-4b23-9b5f-02c88afb80ae)

Company: https://www.keypedia.com/companies/reed-lane-inc/e035bebf-a204-4064-9cb5-92b6957273e7

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248